Training & Education
Individuals at UCI engaged in human subjects research must complete one of the following to meet the basic human research protections training requirement:
- CITI Basic HRP Course for Biomedical Investigators, or
- CITI Basic HRP Course for Social and Behavioral Investigators
Completion of one of these CITI tutorials. Is required for individuals (i.e., Lead Researcher, Co-Investigators, Research Personnel and Faculty Sponsors) who wish to engage in human subject research at UCI before submission of IRB documentation. Individuals may choose the course that best matches their research activities.
"Optional" Training that May be Required by Certain Funding Sponsors
CITI Good Clinical Practice (GCP) Training
Effective in 2017, NIH (NOT-OD-16-148) specified that investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials, should be trained in GCP. The U.S. Food and Drug Administration (FDA) also requires GCP compliance for studies conducted under an investigational new drug application or investigational device exemption.
- CITI provides the following GCP courses which may be required (please refer to your sponsor for applicability):
- Good Clinical Practice (US FDA focus), and Refresher Course
- GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus), and a Refresher Course
- GCP for Clinical Investigations of Device, and a Refresher Course
- GCP - Social and Behavioral Research Best Practices for Clinical research
Good Clinical Practice (GCP) Training for Social and Behavioral Research
In 2017, the NIH Clinical and Translational Science Awards (CTSA) Program project team recognized a critical need for training in applying GCP principles to social and behavioral research, when they published Best Practices in Social and Behavioral Research.
Additional Recommended Learning
- General Informed Consent Requirements OHRP: General Informed Consent Requirements
- Research Use of Human Biological Specimens and Other Private Information: On HHS YouTube Channel
- Reviewing and Reporting Unanticipated Problems and Adverse Events: On HHS YouTube Channel
- Institutional Review Board (IRB) Membership On the HHS YouTube Channel
- IRB Records On HHS YouTube Channel (part I) On HHS YouTube Channel (part II)
- Complex Issues with Research Involving Vulnerable Populations On the HHS YouTube Channel
Request for Human Research Protections (HRP) In-Service Training
To request an HRP in-service training, please email the HRP Education and Quality Improvement Program (EQUIP) at firstname.lastname@example.org. Please allow 4 weeks lead time so that we may try to accommodate the request as our calendars and workload permits.